Study of Boserolimab (MK-5890) as Monotherapy and in Comb... | NCT03396445 | Trialant
NCT03396445
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 5, 2025Actual
Enrollment
182Actual
Phase
Phase 1
Conditions
Pharmacokinetics
Solid Tumor
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Interventions
Boserolimab
Pembrolizumab
Pemetrexed
Carboplatin
Nab-paclitaxel
Countries
United States
Chile
Israel
Netherlands
South Korea
Spain
Taiwan
Protocol Section
Identification Module
NCT ID
NCT03396445
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
5890-001
Secondary IDs
ID
Type
Description
Link
MK-5890-001
Other Identifier
MSD
2017-004550-41
EudraCT Number
Brief Title
Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)
Official Title
A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 18, 2018Actual
Primary Completion Date
Sep 27, 2024Actual
Completion Date
Sep 27, 2024Actual
First Submitted Date
Jan 4, 2018
First Submission Date that Met QC Criteria
Jan 4, 2018
First Posted Date
Jan 11, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Sep 9, 2025
Results First Submitted that Met QC Criteria
Oct 13, 2025
Results First Posted Date
Nov 5, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 13, 2025
Last Update Posted Date
Nov 5, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab (MK-3475) in adults. Boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be administered in adults with advanced solid tumors, including endometrial cancer, for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of boserolimab when administered with pembrolizumab, pemetrexed and carboplatin in adults with non-squamous non-small cell lung cancer (NSCLC) and boserolimab when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed.
Detailed Description
Participants receiving boserolimab monotherapy who experience disease progression may be eligible to switch to receiving boserolimab plus pembrolizumab combination therapy at an eligible dose for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.
Per protocol, pharmacokinetic (PK) outcome measures will not be analyzed separately for the switch-over treatment arms.
Conditions Module
Conditions
Pharmacokinetics
Solid Tumor
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Keywords
Programmed Cell Death Receptor 1 (PD-1)
Programmed Cell Death Receptor Ligand 1 (PD-L1)
Programmed Cell Death Receptor Ligand 2 (PD-L2)
PD-1
PDL1
PD-L1
PD-L2
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
182Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1 Boserolimab 2 mg Q3W
Experimental
Participants receive boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Arm 1 Boserolimab 7 mg Q3W
Experimental
Participants receive boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Arm 1 Boserolimab 20 mg Q3W
Experimental
Participants receive boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Arm 1 Boserolimab 70 mg Q3W
Experimental
Participants receive boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Arm 1 Boserolimab 200 mg Q3W
Experimental
Participants receive boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Boserolimab
Drug
IV infusion
Arm 1 Boserolimab 2 mg Q3W
Arm 1 Boserolimab 20 mg Q3W
Arm 1 Boserolimab 200 mg Q3W
Arm 1 Boserolimab 7 mg Q3W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing >25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs is reported.
Up to 21 days in Cycle 1
Number of Participants With One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced one or more AEs is reported.
Up to approximately 78 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE is reported.
Up to 23 months
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab
AUC0-last was defined as the area under the concentration versus time curve for boserolimab from 0 to the time of the last quantifiable concentration in serum. Samples were taken predose and at specified times postdose to determine the AUC0-last of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit
Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC
Arm 4: Triple-negative breast cancer (TNBC) that is locally recurrent, inoperable, not previously treated with chemotherapy, and which cannot be treated with curative intent OR metastatic disease not previously treated with chemotherapy
Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of boserolimab or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period
Female participants must not be pregnant or breastfeeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of boserolimab or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents
Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample)
Exclusion Criteria:
History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
Clinically active central nervous system metastases and/or carcinomatous meningitis
Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment
Active infection requiring systemic treatment
History of interstitial lung disease
History of (noninfectious) pneumonitis that required steroids or current pneumonitis
Symptomatic ascites or pleural effusion
Previously had a stem cell or bone marrow transplant
Previously had a solid organ transplant
Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy
Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections
Not fully recovered from any effects of major surgery without significant detectable infection
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade ≤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
Expected to require any other form of antineoplastic therapy while participating in this study
On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication
Regular user (including "recreational use") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator
Received a live-virus vaccine within 28 days before the first dose of study treatment
Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment
Additional Exclusion Criteria for Participants in Arm 3:
Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Is unable or unwilling to take folic acid or vitamin B12 supplementation
Additional Exclusion Criteria for Participants in Arm 4:
Has a known history of hypersensitivity or allergy to nab-paclitaxel or any of its components
Has neuropathy ≥Grade 2
Has a history of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization
Has received previous treatment with immune checkpoint inhibitor(s) (eg, Programmed Cell Death Receptor 1 (PD-1)/PD-L1)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of South Alabama, Mitchell Cancer Institute ( Site 0020)
Per protocol, pharmacokinetic (PK) outcome measures were not analyzed separately for the switch-over treatment arms.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
FG001
Arm 1 Boserolimab 7 mg Q3W
Periods
Title
Milestones
Reasons Not Completed
Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Aug 4, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Boserolimab
Arm 1 Boserolimab 700 mg Q3W
Experimental
Participants receive boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Drug: Boserolimab
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Experimental
Participants with endometrial cancer receive boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Participants receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Participants receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Participants receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Participants receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Participants receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Participants with triple-negative breast cancer (TNBC) receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Participants with endometrial cancer receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.
Participants with endometrial cancer receive separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once every 6 weeks (Q6W) on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab is administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle is 6 weeks long.
Participants with non-small cell lung cancer (NSCLC) receive separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab is administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin is administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle is 3 weeks long.
Participants with TNBC receive separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab are administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel is administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle is 6 weeks long
Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Area Under the Concentration-Time Curve From Time 0 to 3 Weeks (AUC0-3w) of Boserolimab
AUC0-3w was defined as the area under the concentration versus time curve for boserolimab from 0 to 3 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-3w of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1.
Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Area Under the Concentration-Time Curve From Time 0 to 6 Weeks (AUC0-6w) of Boserolimab
AUC0-6w was defined as the area under the concentration versus time curve for boserolimab from 0 to 6 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-6w of boserolimab. As pre-specified in the protocol, different arms had different sampling schedules and cycle lengths and therefore AUC0-6w was not analyzed for all Arms; AUC0-6w was only analyzed for Arms 2c and 4 which had 6-week cycles.
Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 Cycle 2
Minimum Concentration (Cmin) of Boserolimab
Cmin of boserolimab was defined as the minimum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmin of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Maximum Concentration (Cmax) of Boserolimab
Cmax of boserolimab was defined as the maximum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmax of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. As pre-specified in the protocol, ORR was analyzed for participants treated with boserolimab when used as monotherapy in Arm 1a, in combination with pembrolizumab in Switch-over Arm 1a and Arms 2a, 2b, and 2c, or in combination with pembrolizumab + nab-paclitaxel in Arm 4. Per protocol, ORR was not analyzed in Arms 1, 2, or 3. The percentage of participants who experienced a CR or PR, as assessed by the investigator, is reported.
Up to approximately 78 months
Arm 3: Number of Participants Who Experienced a DLT
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing >25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 3 is reported
Up to 21 days in Cycle 1
Arm 4: Number of Participants Who Experienced a DLT
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing >25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 4 is reported.
Up to 28 days in Cycle 1
Arm 3 and 4: Number of Participants With One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 and 4 who experienced one or more AEs is reported.
Up to 57 months
Arm 3 and 4: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 or 4 who discontinued study treatment due to an AE is reported.
Up to 27 months
Florida Cancer Specialists ( Site 0002)
Sarasota
Florida
34232
United States
The West Clinic, P.C. ( Site 0021)
Germantown
Tennessee
38138
United States
FALP-UIDO ( Site 0502)
Santiago
Region M. de Santiago
6900941
Chile
Bradfordhill-Clinical Area ( Site 0501)
Santiago
Region M. de Santiago
8420383
Chile
Soroka Medical Center-Oncology ( Site 0012)
Beersheba
8400000
Israel
Hadassah Ein Kerem Medical Center ( Site 0010)
Jerusalem
9112001
Israel
The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)
Ramat Gan
5265601
Israel
Antoni van Leeuwenhoek Ziekenhuis ( Site 0003)
Amsterdam
North Holland
1066 CX
Netherlands
Erasmus MC ( Site 0031)
Rotterdam
South Holland
3015 GD
Netherlands
Seoul National University Hospital-Internal Medicine ( Site 0702)
Seoul
03080
South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0701)
Seoul
03722
South Korea
Hospital Universitario Quiron Madrid ( Site 0043)
Pozuelo de Alarcón
Madrid
28223
Spain
Instituto Catalan de Oncologia - ICO ( Site 0044)
Barcelona
08916
Spain
Hospital Universitario Fundacion Jimenez Diaz ( Site 0041)
Madrid
28040
Spain
Centro Integral Oncologico Clara Campal START Madrid ( Site 0040)
Madrid
28050
Spain
National Taiwan University Hospital-Oncology ( Site 0801)
Taipei
100
Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0802)
Taipei
112
Taiwan
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
FG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
FG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
FG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
FG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
FG006
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once every 6 weeks (Q6W) on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
FG017
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
FG018
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
FG019
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
FG020
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
FG021
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
FG022
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
FG023
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
FG024
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
FG025
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0033 subjects
FG0049 subjects
FG0052 subjects
FG00614 subjects
FG0073 subjects
FG0083 subjects
FG0094 subjects
FG0107 subjects
FG01114 subjects
FG01231 subjects
FG01315 subjects
FG01414 subjects
FG01510 subjects
FG01641 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Treated
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0033 subjects
FG0048 subjects
FG0052 subjects
FG00614 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG0107 subjects
FG01114 subjects
FG01230 subjects
FG01315 subjects
FG01413 subjects
FG01510 subjects
FG01641 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0121 subjects
FG0131 subjects
FG0141 subjects
FG0152 subjects
FG01622 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0026 subjects
FG0033 subjects
FG0049 subjects
FG0052 subjects
FG00614 subjects
FG0073 subjects
FG0083 subjects
FG0094 subjects
FG0107 subjects
FG01112 subjects
FG01230 subjects
FG01314 subjects
FG01413 subjects
FG0158 subjects
FG01619 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG0043 subjects
FG0052 subjects
FG0065 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG0107 subjects
FG01112 subjects
FG01228 subjects
FG01314 subjects
FG01410 subjects
FG0158 subjects
FG01618 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
FG0220 subjects
FG0230 subjects
FG0240 subjects
FG0250 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized by Mistake without Study Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Progressive Disease, Switched Over to Boserolimab + Pembrolizumab Combination Treatment
FG0001 subjects
FG0011 subjects
FG0025 subjects
FG0032 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Switch-over Period
Type
Comment
Milestone Data
STARTED
Per protocol, participants who experience disease progression in boserolimab monotherapy Arms 1 or 1a had the option, at the investigator's discretion and after consultation with the Sponsor, to switch over to boserolimab + pembrolizumab combination therapy at an eligible dose.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
FG0181 subjects
FG0192 subjects
FG0203 subjects
FG0212 subjects
FG0222 subjects
FG0232 subjects
FG0241 subjects
FG0259 subjects
Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Per protocol, baseline characteristics were not analyzed separately for the switch-over period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
BG001
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
BG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
BG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
BG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
BG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
BG006
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
BG017
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0026
BG0033
BG0049
BG0052
BG00614
BG0073
BG0083
BG0094
BG0107
BG01114
BG01231
BG01315
BG01414
BG01510
BG01641
BG017182
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00055.3± 18.9
BG00157.3± 18.0
BG00257.0± 15.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab
AUC0-last was defined as the area under the concentration versus time curve for boserolimab from 0 to the time of the last quantifiable concentration in serum. Samples were taken predose and at specified times postdose to determine the AUC0-last of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available AUC0-last data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*μg/mL
Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
ID
Title
Description
OG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
OG001
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Units
Counts
Participants
OG0003
OG0011
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.761± 179
OG0017.61± NAMethod of dispersion could not be estimated due to n=1.
OG00244.4± 28.6
Primary
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing >25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs is reported.
All participants in Arms 1, 1a, 2, 2a, 2b, 2c, and Switch-over Arms who received ≥1 dose of study treatment and who were observed for DLTs for up to 21 days following the first dose of study treatment in Cycle 1. As pre-specified in the protocol, DLTs were analyzed separately for the Switch-over Arms.
Posted
Count of Participants
Participants
Up to 21 days in Cycle 1
ID
Title
Description
OG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
OG001
Primary
Number of Participants With One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced one or more AEs is reported.
All participants in Arms 1, 1a, 2, 2a, 2b, 2c, and Switch-over Arms who received ≥1 dose of study treatment. As pre-specified in the protocol, safety data were analyzed separately for the Switch-over Arms.
Posted
Count of Participants
Participants
Up to approximately 78 months
ID
Title
Description
OG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
OG001
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Primary
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE is reported.
All participants in Arms 1, 1a, 2, 2a, 2b, 2c, and Switch-over Arms who received ≥1 dose of study treatment. As pre-specified in the protocol, safety data were analyzed separately for the Switch-over Arms.
Posted
Count of Participants
Participants
Up to 23 months
ID
Title
Description
OG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
OG001
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Secondary
Area Under the Concentration-Time Curve From Time 0 to 3 Weeks (AUC0-3w) of Boserolimab
AUC0-3w was defined as the area under the concentration versus time curve for boserolimab from 0 to 3 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-3w of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1.
All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available AUC0-3w data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*μg/mL
Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
ID
Title
Description
OG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
OG001
Arm 1 Boserolimab 7 mg Q3W
Secondary
Area Under the Concentration-Time Curve From Time 0 to 6 Weeks (AUC0-6w) of Boserolimab
AUC0-6w was defined as the area under the concentration versus time curve for boserolimab from 0 to 6 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-6w of boserolimab. As pre-specified in the protocol, different arms had different sampling schedules and cycle lengths and therefore AUC0-6w was not analyzed for all Arms; AUC0-6w was only analyzed for Arms 2c and 4 which had 6-week cycles.
All participants in Arms 2c and 4 who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available AUC0-6w data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*μg/mL
Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 Cycle 2
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Secondary
Minimum Concentration (Cmin) of Boserolimab
Cmin of boserolimab was defined as the minimum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmin of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available Cmin data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.
Posted
Mean
Standard Deviation
μg/mL
Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
ID
Title
Description
OG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
OG001
Arm 1 Boserolimab 7 mg Q3W
Secondary
Maximum Concentration (Cmax) of Boserolimab
Cmax of boserolimab was defined as the maximum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmax of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 of Cycle 2.
All participants who complied with the protocol sufficiently to ensure that the data was likely to exhibit the effects of treatment, according to the underlying scientific model, and who had available Cmax data from ≥1 study treatment. As pre-specified in the protocol, PK outcomes were not analyzed separately for the Switch-over Arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
ID
Title
Description
OG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
OG001
Arm 1 Boserolimab 7 mg Q3W
Secondary
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. As pre-specified in the protocol, ORR was analyzed for participants treated with boserolimab when used as monotherapy in Arm 1a, in combination with pembrolizumab in Switch-over Arm 1a and Arms 2a, 2b, and 2c, or in combination with pembrolizumab + nab-paclitaxel in Arm 4. Per protocol, ORR was not analyzed in Arms 1, 2, or 3. The percentage of participants who experienced a CR or PR, as assessed by the investigator, is reported.
All participants in Arm 1a, 2a, 2b, 2c, 4, and Switch-over Arm 1a with a baseline scan who demonstrated measurable disease by investigator assessment, and who were administered at least 1 dose of study treatment.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 78 months
ID
Title
Description
OG000
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Arm 3: Number of Participants Who Experienced a DLT
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing >25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 3 is reported
All participants in Arm 3 who received ≥1 dose of study treatment and who were observed for DLTs for up to 21 days following the first dose of study treatment in Cycle 1.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Secondary
Arm 4: Number of Participants Who Experienced a DLT
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing >25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs in Arm 4 is reported.
All participants in Arm 4 who received ≥1 dose of study treatment and who were observed for DLTs for up to 28 days following the first dose of study treatment in Cycle 1.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Secondary
Arm 3 and 4: Number of Participants With One or More AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 and 4 who experienced one or more AEs is reported.
All participants in Arms 3 or 4 who received ≥1 dose of study treatment.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Secondary
Arm 3 and 4: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Arms 3 or 4 who discontinued study treatment due to an AE is reported.
All participants in Arms 3 or 4 who received ≥1 dose of study treatment.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Time Frame
Up to approximately 78 months
Description
Serious & other AEs: all participants who received ≥1 dose of study drug. All-Cause Mortality (ACM): all enrolled participants. Per protocol, progression of cancer under study was not considered an AE unless related to study drug; MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. ACM and AEs are reported according to the treatment received by the participant at the time of the event.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Arm 1 Boserolimab 2 mg Q3W
Participants received boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
2
3
1
3
3
3
EG001
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
2
3
0
3
3
3
EG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
1
6
0
6
6
6
EG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
1
3
0
3
3
3
EG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
3
9
1
8
8
8
EG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
2
2
1
2
2
2
EG006
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
18
41
13
41
40
41
EG017
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
0
1
0
1
1
1
EG018
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
1
1
0
1
1
1
EG019
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
2
2
1
2
2
2
EG020
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
2
3
1
3
3
3
EG021
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
1
2
0
2
2
2
EG022
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
2
2
2
2
2
2
EG023
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
0
2
0
2
2
2
EG024
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
1
1
0
1
1
1
EG025
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
6
9
3
9
8
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pericarditis constrictive
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected14 at risk
EG0121 events1 affected30 at risk
EG0130 events0 affected15 at risk
EG0140 events0 affected13 at risk
EG0150 events0 affected10 at risk
EG0160 events0 affected41 at risk
EG0170 events0 affected1 at risk
EG0180 events0 affected1 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected3 at risk
EG0210 events0 affected2 at risk
EG0220 events0 affected2 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected1 at risk
EG0250 events0 affected9 at risk
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Immune-mediated gastritis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Complication associated with device
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Sudden death
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Wound infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Post procedural haematuria
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected2 at risk
EG0062 events2 affected14 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events1 affected3 at risk
EG0100 events0 affected7 at risk
EG0112 events2 affected14 at risk
EG0121 events1 affected30 at risk
EG0132 events2 affected15 at risk
EG0141 events1 affected13 at risk
EG0155 events5 affected10 at risk
EG01654 events18 affected41 at risk
EG0174 events1 affected1 at risk
EG0180 events0 affected1 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected3 at risk
EG0211 events1 affected2 at risk
EG0220 events0 affected2 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected1 at risk
EG0251 events1 affected9 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lymphadenopathy mediastinal
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eye discharge
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Keratitis
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Scleral disorder
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events3 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events4 affected6 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral dysaesthesia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tongue disorder
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0024 events4 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Axillary pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Face oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0002 events2 affected3 at risk
EG0012 events2 affected3 at risk
EG0023 events3 affected6 at risk
EG003
Feeling of body temperature change
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Localised oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Malaise
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Swelling face
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Xerosis
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Body tinea
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eye infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Genital infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Herpes ophthalmic
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lip infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Mucosal infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oral infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0013 events2 affected3 at risk
EG0022 events1 affected6 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Radiation necrosis
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood glucose increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood iron decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood sodium increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac murmur
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Serum ferritin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Transaminases increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Weight increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected6 at risk
EG003
Myalgia intercostal
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vertebral column mass
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bell's palsy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
VIth nerve paresis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urogenital fistula
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Breast inflammation
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Coital bleeding
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eosinophilic pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Scar pain
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected6 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Skin reaction
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Haematoma
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Vena cava embolism
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial prior to submission. Any information identified by the Sponsor as confidential must be deleted prior to submission. This confidentiality does not include efficacy and safety results. The Sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the Sponsor will generally support publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
3
OG0048
OG0052
OG00614
OG0072
OG0083
OG0092
OG0107
OG01114
OG01230
OG01315
OG01411
OG01510
OG01640
OG003
150
± 14.2
OG004469± 42.9
OG005918± 21.4
OG00644.4± 51.7
OG0070.816± 20.8
OG0083.9± 117
OG00926.1± 38.5
OG01084.5± 192
OG011646± 16.3
OG01241.5± 109
OG01344.9± 68.6
OG01447.5± 58.5
OG01541.6± 44.5
OG01662.9± 57.8
Arm 1 Boserolimab 7 mg Q3W
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG006
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
OG015
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG016
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG017
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG018
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG019
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG020
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG021
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG022
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG023
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0033
OG0048
OG0052
OG00614
OG0073
OG0083
OG0093
OG0107
OG01114
OG01230
OG01315
OG01413
OG0151
OG0161
OG0172
OG0183
OG0192
OG0202
OG0212
OG0221
OG0239
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0052
OG0060
OG0070
OG0080
OG0090
OG0101
OG0110
OG0120
OG0130
OG0141
OG0150
OG0160
OG0170
OG0180
OG0190
OG0200
OG0210
OG0220
OG0231
OG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG006
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
OG015
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG016
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG017
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG018
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG019
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG020
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG021
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG022
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG023
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0033
OG0048
OG0052
OG00614
OG0073
OG0083
OG0093
OG0107
OG01114
OG01230
OG01315
OG01413
OG0151
OG0161
OG0172
OG0183
OG0192
OG0202
OG0212
OG0221
OG0239
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0026
OG0033
OG0048
OG0052
OG00614
OG0073
OG0083
OG0093
OG0107
OG01114
OG01230
OG01315
OG01413
OG0151
OG0161
OG0172
OG0183
OG0192
OG0202
OG0212
OG0221
OG0238
OG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG006
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
OG015
Switch-over Arm 1 Boserolimab 2 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 2 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG016
Switch-over Arm 1 Boserolimab 7 mg Q3W To Boserolimab 2 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 7 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG017
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 7 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG018
Switch-over Arm 1 Boserolimab 20 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 20 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG019
Switch-over Arm 1 Boserolimab 70 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 70 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG020
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 20 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG021
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 70 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG022
Switch-over Arm 1 Boserolimab 200 mg Q3W To Boserolimab 200 mg + Pembrolizumab 200 mg Q3W
Qualified participants who received boserolimab 200 mg via IV infusion in Arm 1 but experienced disease progression switched over to receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
OG023
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0033
OG0048
OG0052
OG00614
OG0073
OG0083
OG0093
OG0107
OG01114
OG01230
OG01315
OG01413
OG0151
OG0161
OG0172
OG0183
OG0192
OG0202
OG0212
OG0221
OG0239
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
OG0060
OG0070
OG0081
OG0090
OG0101
OG0111
OG0124
OG0131
OG0142
OG0150
OG0160
OG0170
OG0181
OG0190
OG0200
OG0210
OG0220
OG0232
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG006
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Units
Counts
Participants
OG0003
OG0011
OG0023
OG0033
OG0048
OG0052
OG00614
OG0072
OG0083
OG0092
OG0107
OG01114
OG01230
OG01315
OG01411
OG01510
OG01640
Title
Denominators
Categories
Title
Measurements
OG0001.79± 111
OG0017.77± NAMethod of dispersion could not be estimated due to n = 1
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Units
Counts
Participants
OG00011
OG00140
Title
Denominators
Categories
Title
Measurements
OG00055± 49.2
OG00168.3± 45.4
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG006
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Units
Counts
Participants
OG0003
OG0012
OG0023
OG0032
OG0045
OG0051
OG00613
OG0072
OG0082
OG0093
OG0105
OG01113
OG01226
OG01315
OG01410
OG0159
OG01636
Title
Denominators
Categories
Title
Measurements
OG000NA± NAFor all 3 participants, plasma concentrations of boserolimab were below the limits of quantitation.
OG0010.0689± 0.0975
OG0020.421± 0.103
OG0033.55± 0.573
OG00415.5± 8.08
OG00524.3± NAMethod of dispersion could not be estimated due to n = 1
OG0060.617± 0.498
OG007NA± NAFor all 2 participants, plasma concentrations of boserolimab were below the limits of quantitation.
OG0080.0283± 0.0400
OG0090.0629± 0.0575
OG0103.55± 3.37
OG01116.2± 5.14
OG0120.721± 0.505
OG0130.610± 0.499
OG0140.126± 0.258
OG0150.471± 0.473
OG0160.158± 0.340
Participants received boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG002
Arm 1 Boserolimab 20 mg Q3W
Participants received boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG003
Arm 1 Boserolimab 70 mg Q3W
Participants received boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG004
Arm 1 Boserolimab 200 mg Q3W
Participants received boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG005
Arm 1 Boserolimab 700 mg Q3W
Participants received boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
OG006
Arm 1a Boserolimab 30 mg Q3W (Endometrial)
Participants with endometrial cancer received boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants received separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Participants with non-small cell lung cancer (NSCLC) received separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab was administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin was administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle was 3 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
Units
Counts
Participants
OG0003
OG0011
OG0023
OG0033
OG0048
OG0052
OG00614
OG0072
OG0083
OG0092
OG0107
OG01114
OG01230
OG01315
OG01411
OG01510
OG01640
Title
Denominators
Categories
Title
Measurements
OG0001.15± 175
OG0013.32± NAMethod of dispersion could not be estimated due to n = 1
OG0028.16± 28.6
OG00321.6± 22
OG00467.8± 23.1
OG005105± 8.71
OG0067.24± 46.7
OG0070.656± 5.08
OG0081.75± 5.75
OG0094.9± 39
OG01026.9± 37
OG01183.2± 16.6
OG0127.89± 70.2
OG0138.68± 24.6
OG0148.27± 37.4
OG0157.44± 37.3
OG0169.39± 33.2
Participants with triple-negative breast cancer (TNBC) received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle was 3 weeks long.
Participants with endometrial cancer received separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab was administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle was 6 weeks long.
Participants with TNBC received separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m^2. Boserolimab and pembrolizumab were administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel was administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle was 6 weeks long.
OG005
Switch-over Arm 1a Boserolimab 30mg Q3W (Endometrial) To Boserolimab 30mg + Pembrolizumab 200mg Q3W
Qualified participants who received boserolimab 30 mg via IV infusion in Arm 1a but experienced disease progression switched over to receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab were administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years) after switch-over. Each cycle was 3 weeks long.
Units
Counts
Participants
OG00014
OG00130
OG00215
OG00313
OG00441
OG0059
Title
Denominators
Categories
Title
Measurements
OG0007.1(0.2 to 33.9)
OG00120.0(7.7 to 38.6)
OG00213.3(1.7 to 40.5)
OG0030.0(0.0 to 24.7)
OG00453.7(37.4 to 69.3)
OG00511.1(0.3 to 48.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Difference in percentage of participants who experienced a CR or PR (Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W [Endometrial] - Arm 1a Boserolimab 30 mg Q3W [Endometrial])
Difference in Percent
6.2
2-Sided
95
-21.2
32.8
Comparison based on Miettinen & Nurminen method
Other
OG000
OG003
Difference in percentage of participants who experienced a CR or PR (Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W [Endometrial] - Arm 1a Boserolimab 30 mg [Endometrial])
Difference in Percentage
-7.1
2-Sided
95
-32.1
17.2
Comparison based on Miettinen & Nurminen method
Other
OG002
OG003
Difference in percentage of participants who experienced a CR or PR (Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W [Endometrial] - Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W [Endometrial])